Flexible, multiple-compartment drug container and method of making and using same

• US 5,944,709 A
• Filed: 04/11/1997
• Issued: 08/31/1999
• Est. Priority Date: 05/13/1996
• Status: Expired due to Term

• Current Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG)
• Original Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG)
• Inventors: Smith, Steven L., Gharibian, Noel, Sacca, Giuseppe, York, Walter A., Walter, William V., Young, H. Theodore, Wu, Nicholas Chung-Hui, Harvey, Douglas G., Peara, Christopher D., Sandberg, Sharilyn J., Barney, Ward W., McLonis, Mark R.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): Cho, David J.
• Application Number:
  US08/837,927
• Time in Patent Office: 872 Days
• Field of Search: 604/82, 604/85, 604/87, 604/89-91, 604/408-410, 604/416, 604/56, 206/219, 206/221, 206/568, 206/438, 383/38, 383/39, 383/41, 383/111, 428/412, 428/426
• US Class Current: 604/410
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61J 1/16 Holders for containers
• CPC Class Codes: A61J 1/2024 having peelable seals
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: B29C 2793/0027 Cutting off
• CPC Class Codes: B29C 2793/009 after shaping
• CPC Class Codes: B29C 49/0005 characterised by the material
• CPC Class Codes: B29C 49/0691 using sheet like material, e.g. sheet blow-moulding from joined sheets
• CPC Class Codes: B29C 65/00 Joining or sealing of preformed parts , e.g. welding of plastics materials; Apparatus therefor general aspects of processes or apparatus for joining preformed parts B29C66/00; using porous material formed by internal pressure generated therein for joining preformed parts B29C44/1228, B29C44/326
• CPC Class Codes: B29C 65/02 by heating, with or without pressure
• CPC Class Codes: B29C 65/18 using heated tools
• CPC Class Codes: B29C 65/76 Making non-permanent or releasable joints
• CPC Class Codes: B29C 66/112 Single lapped joints
• CPC Class Codes: B29C 66/1122 Single lap to lap joints, i.e. overlap joints B29C66/45, B29C66/472, B29C66/52272 take precedence
• CPC Class Codes: B29C 66/131 Single flanged joints, i.e. one of the parts to be joined being rigid and flanged in the joint area
• CPC Class Codes: B29C 66/133 Fin-type joints, the parts to be joined being flexible the parts to be joined being rigid B29C66/1312
• CPC Class Codes: B29C 66/242 said joint lines being closed, i.e. forming closed contours
• CPC Class Codes: B29C 66/53262 Enclosing spouts between the walls of bags, e.g. of medical bags
• CPC Class Codes: B29C 66/71 : characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/72321 : consisting of metals or their alloys
• CPC Class Codes: B29C 66/7234 : comprising a barrier layer
• CPC Class Codes: B29C 66/72341 : for gases
• CPC Class Codes: B29C 66/72343 : for liquids
• CPC Class Codes: B29C 66/80 : General aspects of machine operations or constructions and parts thereof
• CPC Class Codes: B29C 66/8322 : Joining or pressing tools reciprocating along one axis
• CPC Class Codes: B29K 2009/06 : SB polymers, i.e. butadiene-styrene polymers
• CPC Class Codes: B29K 2023/06 : PE, i.e. polyethylene
• CPC Class Codes: B29K 2023/0641 : MDPE, i.e. medium density polyethylene
• CPC Class Codes: B29K 2023/065 : HDPE, i.e. high density polyethylene
• CPC Class Codes: B29K 2023/08 : Copolymers of ethylene B29K2023/16 takes precedence
• CPC Class Codes: B29K 2023/083 : EVA, i.e. ethylene vinyl acetate copolymer
• CPC Class Codes: B29K 2023/086 : EVOH, i.e. ethylene vinyl alcohol copolymer
• CPC Class Codes: B29K 2023/10 : Polymers of propylene
• CPC Class Codes: B29K 2023/12 : PP, i.e. polypropylene
• CPC Class Codes: B29K 2025/08 : Copolymers of styrene, e.g. AS or SAN, i.e. acrylonitrile styrene B29K2055/02 takes precedence
• CPC Class Codes: B29K 2027/08 : PVDC, i.e. polyvinylidene chloride
• CPC Class Codes: B29K 2027/12 : containing fluorine
• CPC Class Codes: B29K 2067/00 : Use of polyesters or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2067/003 : PET, i.e. poylethylene terephthalate
• CPC Class Codes: B29K 2101/12 : Thermoplastic materials
• CPC Class Codes: B29K 2105/0085 : Copolymers
• CPC Class Codes: B29K 2105/0088 : Blends of polymers
• CPC Class Codes: B29K 2305/02 : Aluminium
• CPC Class Codes: B29K 2705/02 : Aluminium
• CPC Class Codes: B29L 2009/00 : Layered products
• CPC Class Codes: B29L 2009/003 : comprising a metal layer
• CPC Class Codes: B29L 2031/7148 : Blood bags, medical bags
• CPC Class Codes: B31B 2155/00 : Flexible containers made from webs
• CPC Class Codes: B31B 2155/002 : by joining superimposed webs, e.g. with separate bottom webs
• CPC Class Codes: B31B 2170/20 : having multi-layered walls, e.g. laminated or lined
• CPC Class Codes: B31B 2241/00 : Making bags or boxes intended for a specific use
• CPC Class Codes: B31B 70/844 : Applying rigid valves, spouts, or filling tubes
• CPC Class Codes: B32B 15/08 : of synthetic resin
• CPC Class Codes: B32B 27/08 : of synthetic resin
• CPC Class Codes: B32B 27/32 : comprising polyolefins comprising vinyl (co)polymers or acrylic (co)polymers B32B27/30
• CPC Class Codes: B65B 55/16 : by irradiation
• CPC Class Codes: B65D 75/5861 : Spouts B65D75/5811, B65D75/5822 take precedence
• CPC Class Codes: B65D 81/3266 : separated by a common rupturable seal, a clip or other removable fastening device
• CPC Class Codes: C08L 23/0815 : Copolymers of ethene with aliphatic 1-olefins
• CPC Class Codes: C08L 23/142 : at least partially crystalline copolymers of propene with other olefins
• CPC Class Codes: C08L 23/16 : Elastomeric ethene-propene or ethene-propene-diene copolymers, e.g. EPR and EPDM rubbers
• CPC Class Codes: C08L 2666/02 : Organic macromolecular compounds, natural resins, waxes or and bituminous materials
• CPC Class Codes: C08L 2666/04 : Macromolecular compounds according to groups C08L7/00 - C08L49/00, or C08L55/00 - C08L57/00; Derivatives thereof
• CPC Class Codes: C08L 2666/06 : Homopolymers or copolymers of unsaturated hydrocarbons; Derivatives thereof
• CPC Class Codes: C08L 2666/24 : Graft or block copolymers according to groups C08L51/00, C08L53/00 or C08L55/02; Derivatives thereof
• CPC Class Codes: C08L 53/00 : Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 53/02 : of vinyl-aromatic monomers and conjugated dienes
• CPC Class Codes: C08L 53/025 : modified
• CPC Class Codes: Y10T 428/13 : Hollow or container type article [e.g., tube, vase, etc.]
• CPC Class Codes: Y10T 428/1341 : Contains vapor or gas barrier, polymer derived from vinyl chloride or vinylidene chloride, or polymer containing a vinyl alcohol unit

Abstract

A flexible container is provided for the storage and mixing together of diluents and medicaments. The container incorporates multiple compartments, separated by peelable seals, in which the diluents and medicaments are stored. The container is constructed of thermoplastic materials having high oxygen and moisture barrier properties which allows the container to be stored for extended periods of time without degrading the contents. The seals are ruptured by manipulation of the container to thereby mix the contents together for delivery through standard IV arrangement to a patient. The seals are constructed to provide a non-linear resistance characteristic to hydraulic pressure, which causes the seal to peel open completely along its length. The container is folded-over along the line of one of the seals and also includes a locking tab and retaining slot to secure the bag in a folded-over condition.

Claims

1. A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising:

a flexible rear sheet;

a flexible front sheet sealed to the rear sheet along a common peripheral edge;

a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent;

a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment;

a clear high-barrier laminate film separately disposed upon and sealed to the front sheet, the high-barrier laminate film sized to extend over the medicament compartment; and

an opaque high-barrier protective film peelably affixed to the clear high-barrier laminate film, the opaque film sized to extend over the high-barrier laminate film and the medicament compartment.

2. A flexible container as defined in claim 1, wherein the front sheet comprises a polypropylene-polyethylene co-polymer blended with styrene ethylene-butylene styrene elastomer.

3. A flexible container as defined in claim 2, wherein the polypropylene-polyethylene co-polymer is blended with styrene ethylene-butylene styrene elastomer in an about 80%/200% ratio.

4. A flexible container as defined in claim 1, wherein the medicament is a powdered antibiotic.

5. A flexible container as defined in claim 3, wherein the rear sheet comprises a multi-layer laminate including:

an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene elastomer in about an 80%/20% ratio interfacing with the front sheet;

an intermediate layer of aluminum foil; and

an outer thermoplastic layer having a higher melting point than said inner layer.

6. A flexible container as defined in claim 1, wherein the opaque high-barrier protective film is peelably affixed over the clear high-barrier laminate film, whereby said opaque high-barrier protective film contacts only a portion of the surface of the clear high-barrier laminate film, the strength of attachment of the opaque film being directly proportional to the area of surface contact.

7. A flexible container as described in claim 6, wherein the opaque high-barrier protective film is affixed over the clear high-barrier laminate film by a patterned heat seal head, the patterned heat seal head defining a regular array of generally circular non-contact areas.

8. A flexible container as described in claim 6, wherein the opaque high-barrier protective film is affixed over the clear high-barrier laminate film by a uniform heat seal.

9. A flexible container as defined in claim 6, wherein the opaque high-barrier protective film is affixed over the clear high-barrier laminate film by a peelable, peripheral seal.

10. A flexible container as defined in claim 1, wherein the container is folded-over adjacent the first peelable seal such that the folded-over container'"'"'s outwardly facing surface comprises the multi-layer laminate rear sheet, the flexible container further comprising means for securing the container in a folded-over condition.

11. A flexible container as defined in claim 10, wherein the means for securing the container in a folded-over condition comprises:

a locking tab integrally formed with and extending from a side of the container; and

a slot integrally formed with and extending from the same side of the container as the tab, wherein the tab and slot are moved into position for mutual engagement when the container is folded-over adjacent the first peelable seal to thereby secure the container in a folded-over condition.

12. A flexible container as defined in claim 1, wherein the peelable seals are constructed to provide a uniform resistance characteristic to hydraulic pressure against the seal caused by manipulation of the container, the uniform resistance characteristic causing the seal to peel at an applied pressure in the range of three to five pounds per square inch.

13. A flexible container for separately storing and mixing liquid diluent and medicament, the container comprising:

a multi-layer laminate rear sheet including an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene elastomer, an opaque high-barrier intermediate layer, and an outer high temperature resistant mold release layer;

a flexible front sheet constructed of a single layer film of a polypropylene-polyethylene co-polymer blended with styrene ethylene-butylene styrene elastomer interfacing with the rear sheet, the front sheet sealed to the rear sheet along a common peripheral edge;

at least two peelable seals extending between two parallel sides of the common peripheral edge and separably joining the front and rear sheets to define at least three compartments in the container including a first compartment containing a powdered medicament;

a clear high-barrier laminate film sealed to the front sheet, the high-barrier laminate film sealed to extend over the medicament compartment; and

an opaque high-barrier protective film separably sealed to the clear high-barrier laminate film, the opaque film sized to extend over the high-barrier laminate film and the medicament compartment.

14. A flexible container as defined in claim 13, wherein the polypropylene-polyethylene co-polymer of the front and rear sheets is blended with styrene ethylene-butylene styrene elastomer in an about 80%/20% ratio.

15. A flexible container as defined in claim 13, wherein the medicament is a powdered antibiotic.

16. A flexible container as defined in claim 13, wherein the opaque high-barrier protective film is peelably affixed over the clear high-barrier laminate film, whereby said opaque high-barrier protective film contacts only a portion of the surface of the clear high-barrier laminate film, the strength of attachment of the covering being directly proportional to the area of surface contact.

17. A flexible container as described in claim 16, wherein the opaque high-barrier protective film is affixed over the clear high-barrier laminate film by a patterned heat seal head, the patterned heat seal head defining a regular array of generally circular non-contact areas.

18. A flexible container as defined in claim 13, wherein the peelable seals are constructed to provide a uniform resistance characteristic to hydraulic pressure against the seal caused by manipulation of the container, the uniform resistance characteristic causing the seal to peel at an applied force in the range of three to five pounds.

19. A flexible container as defined in claim 16, wherein the opaque high-barrier protective film is affixed over the clear high-barrier laminate film by a peelable, uniform heat seal.

20. A flexible container as defined in claim 16, wherein the opaque high-barrier protective film is affixed over the clear high-barrier laminate film by a peelable, peripheral heat seal.

21. A flexible container as defined in claim 13, wherein the container is folded-over adjacent the first peelable seal such that the folded-over container'"'"'s outwardly facing surface comprises the multi-layer laminate rear sheet, the flexible container further comprising means for securing the container in a folded-over condition.

22. A flexible container as defined in claim 21, wherein the means for securing the container in a folded-over condition comprises:

a locking tab integrally formed with and extending from a side of the container; and

a slot integrally formed with and extending from the same side of the container as the tab, wherein the tab and slot are moved into position for mutual engagement when the container is folded-over adjacent the first peelable seal to thereby secure the container in a folded-over condition.

23. A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising:

a flexible front sheet;

a flexible rear sheet sealed to the front sheet at a common peripheral edge;

a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent; and

a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment, wherein the peelable seals are constructed to provide a uniform resistance characteristic to hydraulic pressure against the seal caused by manipulation of the container, the uniform resistance characteristic causing the seal to peel at an applied pressure in the range of from about 3 to about 5 lbs per square inch.

24. A flexible container as defined in claim 23, wherein the medicament is a powdered antibiotic.

25. A flexible container as defined in claim 23, wherein the front sheet comprises a single layer film constructed of a polypropylene-polyethylene co-polymer blended with styrene-ethylene butylene styrene elastomer.

26. A flexible container as defined in claim 25, wherein the polypropylene-polyethylene co-polymer is blended with styrene ethylene-butylene styrene elastomer in about an 80%/20% wt/wt ratio.

27. A flexible container as defined in claim 23, wherein the rear sheet comprises a multi-layer laminate including:

an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene elastomer in about an 80%/20% wt/wt ratio interfacing with the front sheet;

an intermediate layer of aluminum foil; and

an outer thermo-plastic layer having a higher melting point than said inner layer.

28. A flexible container as defined in claim 27, further comprising a high-barrier protective covering at least a portion of which is separably sealed to the front sheet, the covering sized to extend over the medicament compartment.

29. A flexible container as defined in claim 28, wherein the high-barrier protective covering comprises:

an opaque, peelable, multi-layer laminate including;

a modified ethylenevinylacetate polymer layer comprising the inwardly facing surface of said laminate;

a polyester polymer layer having a higher melting temperature than said modified ethylenevinylacetate polymer layer, comprising the outwardly facing surface of said laminate; and

an aluminum foil layer intermediate the modified ethylenevinylacetate and polyester layers.

30. A flexible container as defined in claim 29, wherein the high-barrier protective covering further comprises:

a clear transparent multi-layer high-barrier film laminate disposed intermediate the front sheet and the opaque, peelable, multi-layer laminate, the transparent high-barrier film laminate including;

a polypropylene inner layer adjacent the front sheet;

an outer layer comprising polyester; and

a clear, transparent high moisture barrier between the inner and outer layers.

31. A flexible container as defined in claim 30, wherein the clear, transparent multi-layer high-barrier film laminate further comprises a clear, transparent, high oxygen barrier film layer disposed intermediate the polypropylene layer and the polyester layer.

32. A flexible container as defined in claim 31, wherein the clear, transparent high moisture barrier film layer is a polymer selected from the group consisting of oriented high-density polyethylene, polychlorotrifluoroethylene, and silica deposited polyethylene terephthalate.

33. A flexible container as defined in claim 31, wherein the clear, transparent high oxygen barrier film layer is a polymer selected from the group consisting of ethylenevinylalcohol, polyvinylidenechloride coated polyethylene terephthalate, and silica deposited polyvinylalcohol.

34. A flexible container as defined in claim 23, wherein the first and second peelable seals comprise:

a first longitudinal portion extending between two parallel sides of the common peripheral edge;

a second longitudinal portion extending between two parallel sides of the common peripheral edge; and

a transverse portion adjacent one of the two parallel sides of the common peripheral edge, the transverse portion joining the first and second longitudinal portions at one end thereof, to form thereby a U shape.

35. A flexible container as defined in claim 34, wherein the transverse portion is formed with its entire length partially overlapping the compartment containing a medicament.

36. A flexible container as defined in claim 23, wherein the first and second peelable seals each comprise a generally rectangular longitudinal seal portion extending between the two sides of the common peripheral edge.

37. A flexible container as defined in claim 23, wherein the container is folded-over adjacent the first peelable seal such that the folded-over container'"'"'s outwardly facing surface comprises the multi-layer laminate rear sheet, the flexible container further comprising means for securing the container in a folded-over condition.

38. A flexible container as defined in claim 37, wherein the means for securing the container in a folded-over condition comprises:

a locking tab integrally formed with and extending from a side of the container; and

a slot integrally formed with and extending from the same side of the container as the tab, wherein the tab and slot are moved into position for mutual engagement when the container is folded-over adjacent the first peelable seal to thereby secure the container in a folded-over condition.

39. A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising:

a flexible rear sheet;

a flexible front sheet sealed to the rear sheet along a common peripheral edge;

a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent;

a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment; and

a third peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby a sacrificial moisture vapor barrier compartment which is intermediate the diluent compartment and the medicament compartment.

40. A flexible container as defined in claim 39, wherein the container is folded-over adjacent the first peelable seal, the flexible container further comprising means for securing the container in a folded-over condition.

41. A flexible container as defined in claim 40, wherein the means for securing the container in a folded-over condition comprises:

a locking tab integrally formed with and extending from a side of the container; and

a slot integrally formed with and extending from the same side of the container as the tab, wherein the tab and slot are moved into position for mutual engagement when the container is folded-over adjacent the first peelable seal to thereby secure the container in a folded-over condition.

42. A flexible container as defined in claim 41 further comprising:

a clear high-barrier laminate film sealed to the front sheet, the high-barrier laminate film sized to extend over the medicament compartment; and

an opaque high-barrier protective film separably sealed to the clear high-barrier laminate film, the opaque film sized to extend over the high-barrier laminate film and the medicament compartment.

43. A flexible container as defined in claim 42, wherein the opaque high-barrier protective covering is peelably affixed over the clear high-barrier laminate film, whereby said opaque high-barrier protective film contacts only a portion of the surface of the clear high-barrier laminate film, the strength of attachment of the opaque film being directly proportional to the area of surface contact.

44. A flexible container as described in claim 43, wherein the opaque high-barrier protective film is affixed over the clear high-barrier laminate film by a patterned heat seal head, the patterned heat seal head defining a regular array of generally circular non-contact areas.

45. A flexible container as defined in claim 39, wherein the peelable seals are constructed to provide a uniform resistance characteristic to hydraulic pressure against the seal caused by manipulation of the container, the uniform resistance characteristic causing the seal to peel at an applied pressure in the range of three to five pounds per square inch.

46. A flexible container as defined in claim 43, wherein the opaque high-barrier protective film is affixed over the clear high-barrier laminate film by a peelable, peripheral heat seal.

47. A flexible container as defined in claim 45, wherein the first and second peelable seals comprise:

a first longitudinal portion extending between two parallel sides of the common peripheral edge;

a second longitudinal portion extending between two parallel sides of the common peripheral edge; and

a transverse portion adjacent one of the two parallel sides of the common peripheral edge, the transverse portion joining the first and second longitudinal portions at one end thereof, to form thereby a U shape.

48. A flexible container as defined in claim 45, wherein the transverse portion is formed with its entire length partially overlapping the compartment containing a medicament.

49. A flexible container as defined in claim 45, wherein the first and second peelable seals each comprise a generally rectangular longitudinal seal portion extending between the two sides of the common peripheral edge.

50. A flexible container as defined in claim 42, wherein the opaque, high-barrier protective film comprises:

an opaque, peelable, multi-layer laminate including;

a modified ethylenevinylacetate polymer layer comprising the inwardly facing surface of said laminate;

a polyester polymer layer, having a higher melting temperature than said modified ethylenevinylacetate polymer layer comprising the outwardly facing surface of said laminate; and

an aluminum foil layer intermediate the modified ethylenevinylacetate and polyester layers.

51. A flexible container as defined in claim 42, wherein the clear high-barrier laminate film comprises:

a polypropylene inner layer adjacent the container front sheet;

an outer layer comprising polyester; and

a clear, transparent high-moisture barrier between the inner and outer layers.

52. A flexible container as defined in claim 51, wherein the clear, high-barrier laminate film further comprises a clear, transparent high oxygen barrier film layer intermediate the polypropylene layer and the polyester layer.

53. A flexible container as defined in claim 52, wherein the clear, transparent high moisture barrier film layer is a polymer selected from the group consisting of oriented high-density polyethylene, polychlorotrifluoroethylene, and silica deposited polyethylene terephthalate.

54. A flexible container as defined in claim 53, wherein the clear, transparent high oxygen barrier film layer is a polymer selected from the group consisting of ethylenevinylalcohol, polyvinylidenechloride coated polyethylene terephthalate, and silica deposited polyvinylalcohol.

55. A flexible container for combined storage and administration of medicaments and diluent for IV solutions, the container comprising:

a flexible front sheet;

a flexible rear sheet sealed to the front sheet along a common peripheral edge;

a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent;

a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing medicament which is intermediate the outlet compartment and an diluent compartment, wherein the peelable seals are rupturable by hydraulic pressure against the seal caused by manipulation of the container;

an opaque high-barrier protective film separably sealed to the front sheet, the covering sized to extend over the medicament compartment, whereby the opaque high-barrier protective film contacts only a portion of the surface of the medicament compartment, the strength of attachment of the high-barrier protective film being directly proportional to the are of surface contact;

a locking tab integrally formed and extending from an edge of the container; and

a mating receptacle integrally formed with an extending from the same edge of the container as said locking tab, wherein the container is folded-over adjacent the first peelable seal thereby moving the locking tab into position for engagement with the mating receptacle for securing the container in a folded-over condition.

56. A flexible container as defined in claim 55, wherein the opaque, high-barrier protective film is peelably affixed over the medicament compartment by a patterned heat seal head, the patterned heat seal head defining a regular array of raised, generally circular, non-contact areas.

57. A flexible container as defined in claim 55, wherein the front sheet comprises a polypropylene-polyethylene co-polymer blended with styrene ethylene-butylene styrene elastomer in about an 80%/20% wt/wt ratio.

58. A flexible container as defined in claim 57, wherein the rear sheet comprises a multi-layer laminate including:

an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene elastomer in about an 80%/20% wt/wt ratio interfacing with the front sheet;

an intermediate layer of aluminum foil; and

an outer thermoplastic layer having a higher melting point than said inner layer.

59. A flexible container as defined in claim 58, wherein the opaque, high-barrier protective covering comprises:

an opaque, peelable, multi-layer laminate including;

a modified ethylenevinylacetate polymer layer comprising the inwardly facing surface of said laminate;

a polyester polymer layer, having a higher melting temperature than said modified ethylenevinylacetate polymer layer comprising the outwardly facing surface of said laminate; and

an aluminum foil layer intermediate the modified ethylenevinylacetate and polyester layers.

60. A flexible container as defined in claim 59, further comprising a clear high-barrier laminate film intermediate the opaque, high-barrier protective film, and sealed to the front sheet, the clear, high-barrier laminate film sized to extend over the medicament compartment.

61. A flexible container as defined in claim 60, wherein the clear high-barrier laminate film comprises:

a polypropylene inner layer adjacent the container front sheet;

an outer layer comprising polyester; and

a clear, transparent high-moisture barrier between the inner and outer layers.

62. A flexible container as defined in claim 61, wherein the clear, high-barrier laminate film further comprises a clear, transparent high oxygen barrier film layer intermediate the polypropylene layer and the polyester layer.

63. A flexible container as defined in claim 62, wherein the clear, transparent high moisture barrier film layer is a polymer selected from the group consisting of oriented high-density polyethylene, polychlorotrifluoroethylene, and silica deposited polyethylene terephthalate.

64. A flexible container as defined in claim 63, wherein the clear, transparent high oxygen barrier film layer is a polymer selected from the group consisting of ethylenevinylalcohol, polyvinylidenechloride coated polyethylene terephthalate, and silica deposited polyvinylalcohol.

65. A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising:

a flexible front sheet comprising a single layer film constructed of a polypropylene-polyethylene co-polymer blended with styrene ethylene-butylene styrene elastomer in an about 80%/20% wt/wt ratio;

a flexible rear sheet sealed to the front sheet along a common peripheral edge, the rear sheet constructed of a multi-layer laminate including;

an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene elastomer in about an 80%/20% wt/wt ratio interfacing with the front sheet;

an intermediate layer of aluminum foil; and

an outer thermo plastic layer having a higher melting point than said inner layer;

a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent;

a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment, wherein the peelable seals are rupturable by hydraulic pressure against the seal caused by manipulation of the container;

a clear, transparent multi-layer high-barrier film laminate disposed adjacent the medicament compartment, the transparent high-barrier film laminate including;

a polypropylene inner layer adjacent the front sheet in the region of the medicament compartment;

an outer layer comprising polyester;

a clear, transparent high moisture barrier film layer between the inner and outer layers;

a clear, transparent high oxygen barrier film layer disposed intermediate the polypropylene layer and the polyester-containing thermoplastic layer;

an opaque, peelable, multi-layer laminate separably sealed to the transparent high-barrier film laminate, wherein the opaque multi-layer laminate comprises;

a modified ethylenevinylacetate polymer layer comprising the inwardly facing surface of said laminate;

a polyester polymer layer having a higher melting temperature than said modified ethylenevinylacetate polymer layer, comprising the outwardly facing surface of said laminate; and

an aluminum foil layer intermediate the modified ethylenevinylacetate and polymer layers.

66. A flexible container for combined storage and administration of IV solutions, the container comprising:

a flexible front sheet;

a flexible, rear sheet, the front and rear sheets sealed together at a common peripheral edge so as to define a volume enclosure; and

at least one removable sacrificial port interposed a between the front and rear sheets along a common peripheral edge and in communication with the volume enclosure to thereby form a filling path adapted to allow the volume enclosure to be filled aseptically.

67. The flexible container according to claim 66, further comprising:

a first peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form a first compartment; and

a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby a second compartment and a third compartment which is intermediate the second compartment and the first compartment.

68. The flexible container according to claim 67, the at least one sacrificial port in communication with the first compartment, wherein the flexible container further comprises a second sacrificial port interposed between the front and rear sheets and in communication with the third compartment to thereby form a filling path for allowing the third compartment to be filled aseptically.

69. The flexible container according to claim 68, wherein the first compartment is adapted to contain a liquid diluent, the third compartment is adapted to contain a powdered medicament, and the second compartment is adapted to form an initially empty outlet compartment.

70. The flexible container according to claim 67, wherein the peelable seals are constructed to provide a uniform resistance characteristic to hydraulic pressure against the seal caused by manipulation of the container, the uniform resistance characteristic causing the seal to peel at an applied pressure in the range of from about 3 to about 5 pounds per square inch.

71. The flexible container according to claim 67, wherein the peelable seals comprise:

a first longitudinal portion extending between two parallel sides of the common peripheral edge;

a second longitudinal portion extending between two parallel sides of the common peripheral edge; and

a transverse portion adjacent one of the two parallel sides of the common peripheral edge, the transverse portion joining the first and second longitudinal portions at one end thereof, to form thereby a U shape.

72. A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising:

a flexible rear sheet;

a flexible front sheet sealed to the rear sheet along a common peripheral edge;

a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent;

a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment;

an opaque high-barrier protective film separably sealed to the clear high-barrier laminate film, the opaque film including;

a modified ethylenevinylacetate polymer layer comprising the inwardly facing surface of said laminate;

a polyester polymer layer, having a higher melting temperature than said modified ethylenevinylacetate polymer layer, comprising the outwardly facing surface of said laminate; and

an aluminum foil layer intermediate the modified ethylenevinylacetate and polyester layers.

73. A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising:

a flexible rear sheet;

a flexible front sheet sealed to the rear sheet along a common peripheral edge;

a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent;

a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment;

a clear high-barrier laminate film sealed to the front sheet, the high-barrier laminate film sized to extend over the medicament compartment, the film comprising a polypropylene inner layer adjacent a container front sheet, an outer layer comprising polyester, and a clear, transparent high-moisture barrier between the inner and outer layers; and

an opaque high-barrier protective film separably sealed to the clear high-barrier laminate film, the opaque film sized to extend over the high-barrier laminate film and the medicament compartment.

74. A flexible container as defined in claim 73, wherein the clear, high-barrier laminate film further comprises a clear, transparent high oxygen barrier film layer intermediate the polypropylene layer and the polyester layer.

75. A flexible container as defined in claim 74, wherein the clear, transparent high moisture barrier film layer is a polymer selected from the group consisting of oriented high-density polyethylene, polychlorotrifluoroethylene, and silica deposited polyethylene terephthalate.

76. A flexible container as defined in claim 75, wherein the clear, transparent high oxygen barrier film layer is a polymer selected from the group consisting of ethylenevinylalcohol, polyvinylidenechloride coated polyethylene terephthalate, and silica deposited polyvinylalcohol.

77. A flexible container for separately storing and mixing liquid diluent and medicament, the container comprising:

a multi-layer laminate rear sheet including an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene butadiene elastomer, an opaque high-barrier intermediate layer, and an outer high temperature resistant mold release layer;

a flexible front sheet constructed of a single layer film of a polypropylene-polyethylene co-polymer blended with styrene butadiene elastomer interfacing with the rear sheet, the front sheet sealed to the rear sheet along a common peripheral edge;

at least two peelable seals extending between two parallel sides of the common peripheral edge and separably joining the front and rear sheets to define at least three compartments in the container including a first compartment containing a powdered medicament;

a clear high-barrier laminate film sealed to the front sheet, the high-barrier laminate film sized to extend over the medicament compartment; and

an opaque high-barrier protective film separably sealed to the clear high-barrier laminate film, the opaque film sized to extend over the high-barrier laminate film and the medicament compartment, the opaque film comprising;

a modified ethylenevinylacetate polymer layer comprising an inwardly facing surface;

a polyester polymer layer, having a higher melting temperature than said modified ethylenevinylacetate polymer layer, comprising the outwardly facing surface; and

an aluminum foil layer intermediate the modified ethylenevinylacetate and polyester layers.

78. A flexible container as defined in claim 77, wherein the clear, high-barrier laminate film further comprises a clear, transparent high oxygen barrier film layer intermediate the polypropylene layer and the polyester layer.

79. A flexible container as defined in claim 78, wherein the clear, transparent high moisture barrier film layer is a polymer selected from the group consisting of oriented high-density polyethylene, polychlorotrifluoroethylene, and silica deposited polyethylene terephthalate.

80. A flexible container as defined in claim 79, wherein the clear, transparent high oxygen barrier film layer is a polymer selected from the group consisting of ethylenevinylalcohol, polyvinylidenechloride coated polyethylene terephthalate, and silica deposited polyvinylalcohol.